Painful Diabetic NeuropathyNCT03331614
An Evaluation of an SCCD on the Symptomatology of Painful DPN
A study testing Flowaid FA-100 SCCD in people with Painful Diabetic Neuropathy, run by Rosenblum, Jonathan I., DPM at 1 site in United States.
Trial summary
This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Flowaid FA-100 SCCD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a current diagnosis of Type I or Type II Diabetes Mellitus
- Have a documented diagnosis of Diabetic Peripheral Neuropathy by either their Primary Care Physician or other physician treating their condition made no less than 6 months prior to initiation of the study.
- Have been on stable pain medications (no change to type, dose or frequency) for at least 1 month prior to their entry into the study.Give appropriate written informed consent prior to participation in the study
- Be between 18 and 90 years of age, inclusive, on the day the Informed Consent Form is signed
- Have an average baseline VAS score of 4 or more as assessed during the week just prior to randomization
- Be in reasonable metabolic control, exhibited by HbA1C values of less than 12% as observed by serum test results obtained within 3 months prior to the Screening Visit
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- Be willing to remain on the same pain medication regimen for the duration of the study
- If subject is of childbearing potential, she must be using an acceptable method of birth control. Women not of childbearing potential are defined as either surgically sterile or post-menopausal. Post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the Informed Consent Form.
- Subject and caregiver, if applicable, must be accessible and willing to comply with all requirements of the study protocol for the duration of the study.
Who cannot join
- Clinical evidence of compromised skin (e.g., wound, infection, gangrene) on the lower legs
- Active Charcot's foot on either limb
- Malnourished as evidenced by a pre-albumin of < 11 mg/dL
- Pregnancy or lactating
- Known history of alcohol or drug abuse within the previous one year
- Previous treatment with SCCD
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- Elective osseous procedures performed to either foot 30 days prior to Screening visit
- Vascular procedures performed 30 days prior to Screening Visit
- History of poor compliance to medical treatment regimens
- Conditions that may severely compromise their ability to complete the study.
- Concomitant history of Peripheral Arterial disease with an ABI of <0.5
- Chronic pain due to an etiology other than diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Evan Renov contact
United States1 site, 1 recruiting
- Recruiting
Sean D Rosenblum DPM
Lodi, New Jersey, 07055
Jonathan Rosenblum, DPM, 720-744-3222, diabfootman@gmail.com
Evan Renov, clinicaltrials@flowaid.com
About this study
Official title: A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)
This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Subjects will be evaluated for Subjective Pain levels, quality of life, breakthrough drug use, sleep levels, and objectively with a Quantitative Sensory Testing device. The trial duration is 30 days.
Read the detailed description
This is a controlled trial of 30 days duration to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will have to have been on a sustained drug regimen for more than 30 days and have an average pain level of 4 on a VAS. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Patients will be asked to use the SCCD device daily on both their legs. Subjects will be evaluated for Subjective Pain levels using a Visual Analog Scale, quality of life using various questionnaires, breakthrough drug use in a daily log, sleep levels i.e. how many consecutive hours of sleep, and objectively with a Quantitative Sensory Testing device.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Flowaid FA-100 SCCD
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowaid FA-100 SCCDDevice
The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will continue with their current treatment regimen during the course of the study. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation. |
| Active Treatment Group | Active comparator | This group will continue with their current treatment regimen during the course of the study. In addition they will be given an active intervention with the Flowaid FA-100 SCCD device to utilize at home daily. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation. Receives: Device: Flowaid FA-100 SCCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Subjective Pain
Reduction in pain as measured using a pain descriptive Visual Analog Scale (VAS). The SCCD treatment will be considered effective if the subjects treated with the SCCD demonstrate, on average, a 30% greater reduction in pain on the VAS as compared to the control subjects.
Measured: 30 days
Secondary outcomes (3)
Quantitative Sensation
- The ability of the subject to discriminate temperature and vibration on the bottom of the foot as measured by a quantitative tool.
Measured: 30 days
Analgesic Use
- Improvement in PDN as measured by the change in usage of prescribed regimented and breakthrough medications for analgesia
Measured: 30 days
Quality of Life
- Improved quality of life as measured using the SF36 QOL questionnaire.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Oct 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be sequentially divided into a control group or an active treatment group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rosenblum, Jonathan I., DPM
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331614
- Sponsor's protocol ID
- SCN-1
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No data will be shared with other investigators. Data sent to the data assessor will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Evaluation of the Effect of Sequential Contraction Compression Device on the Symptomatology of Painful Diabetic Neuropathy (PDN)
- ClinicalTrials.gov ID
- NCT03331614
- Acronym / sponsor ID
- SCN-1
- Conditions
- Painful Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rosenblum, Jonathan I., DPM
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a controlled trial to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Subjects will be evaluated for Subjective Pain levels, quality of life, breakthrough drug use, sleep levels, and objectively with a Quantitative Sensory Testing device. The trial duration is 30 days.
Detailed description
This is a controlled trial of 30 days duration to evaluate the efficacy of an Sequential Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy. Subjects will have to have been on a sustained drug regimen for more than 30 days and have an average pain level of 4 on a VAS. Subjects will be divided into a control group where they will be monitored while continuing with their current treatment regimen and into a treatment group where they will continue with their current regimen and have SCCD therapy added. Patients will be asked to use the SCCD device daily on both their legs. Subjects will be evaluated for Subjective Pain levels using a Visual Analog Scale, quality of life using various questionnaires, breakthrough drug use in a daily log, sleep levels i.e. how many consecutive hours of sleep, and objectively with a Quantitative Sensory Testing device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be sequentially divided into a control group or an active treatment group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will continue with their current treatment regimen during the course of the study. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation. |
| Active Treatment Group | Active comparator | Device: Flowaid FA-100 SCCDThis group will continue with their current treatment regimen during the course of the study. In addition they will be given an active intervention with the Flowaid FA-100 SCCD device to utilize at home daily. They will be monitored with daily questionnaires, and at the end of trial visit will also undergo a QST evaluation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a current diagnosis of Type I or Type II Diabetes Mellitus
- Have a documented diagnosis of Diabetic Peripheral Neuropathy by either their Primary Care Physician or other physician treating their condition made no less than 6 months prior to initiation of the study.
- Have been on stable pain medications (no change to type, dose or frequency) for at least 1 month prior to their entry into the study.Give appropriate written informed consent prior to participation in the study
- Be between 18 and 90 years of age, inclusive, on the day the Informed Consent Form is signed
- Have an average baseline VAS score of 4 or more as assessed during the week just prior to randomization
Key exclusion criteria (12 listed)
- Clinical evidence of compromised skin (e.g., wound, infection, gangrene) on the lower legs
- Active Charcot's foot on either limb
- Malnourished as evidenced by a pre-albumin of < 11 mg/dL
- Pregnancy or lactating
- Known history of alcohol or drug abuse within the previous one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flowaid FA-100 SCCDThe SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes. | Device | Active Treatment Group |
Primary outcome
Reduction in Subjective Pain
Time frame: 30 days
Reduction in pain as measured using a pain descriptive Visual Analog Scale (VAS). The SCCD treatment will be considered effective if the subjects treated with the SCCD demonstrate, on average, a 30% greater reduction in pain on the VAS as compared to the control subjects.
3 secondary outcomes
Quantitative Sensation
Time frame: 30 days
Analgesic Use
Time frame: 30 days
Quality of Life
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No. No data will be shared with other investigators. Data sent to the data assessor will be anonymous.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Renov contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flowaid FA-100 SCCD in people with Painful Diabetic Neuropathy, run by Rosenblum, Jonathan I., DPM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Rosenblum, DPM (720-744-3222, diabfootman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Subjective Pain (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.